KENYATTA NATIONAL HOSPITAL/U.O.N/ ETHICS & RESEARCH COMMITTEE GUIDELINES FOR PROTOCOL DEVELOPMENT

KENYATTA NATIONAL HOSPITAL/U.O.N/ ETHICS & RESEARCH COMMITTEE GUIDELINES FOR PROTOCOL DEVELOPMENT

 helb disbursement for continuing students   - 1.    Title

2    Investigators, co-investigators and supervisors where applicable.

      Their addresses and signatures should be included.

      The committee may require their curriculum vitae

3     Any collaborating institution(s).

4    Funding agency where applicable

5    Structured summary (Approximately 200-300 words).

6          a)   Introduction/background
b)  Literature review
7.    Rationale

8.   Study questions, hypothesis/hypotheses where applicable
         
9.     Objectives/Aims
a)    Broad objective(s)/overall goals
b)    Specific objectives
c)    Secondary objectives if applicable

10.   Study design and Methodology
a)    Study design
b)    Study area description
c)    Study population (source and reference)
    -Inclusion/exclusion criteria
d)    Sample size determination and formula/computer programme used
e)    Sampling method
f)    Definition of cases/controls if applicable
g)    Recruitment and consenting procedures
h)    Data collection procedures (qualitative and quantitative data, field, data collection instruments,
i)    Variables – dependent, independent, confounders where applicable.
j)    Materials – equipment, suppliers, personnel
k)    Training procedures if any
l)    Quality assurance procedures
m)    Data collection instruments



   11.  Ethical consideration-briefly explain the ethical issues that may arise and strategies to address them.

12. Data management (data entry, cleaning, storage, security and quality assurance, statistical  analysis plans etc)

13. Study limitations and how to minimize them

14. Timeline/time frame

15. Role of investigators/supervisors where  applicable

16.  References
 Use authors – Date system i.e. (Use internationally accepted format e.g. Vancouver, Harvard e.t.c  must maintain consistency)
     
  17. Budget and budget justification; Consider coverage of such areas
a.    Personnel - salaries and salary disbursements
b.    Training costs
c.    Participants service costs
d.    Supplies and equipment
e.    Animal acquisition where applicable
f.    Travel and accommodation
g.    Transport – vehicles – repair, fuel.
h.    Operating expenses – postage, report writing e.t.c
i.    Consultancy if applicable
j.    Dissemination
k.    Miscellaneous
l.    Contingency (%)

18. Appendices for example:

1.    Consent/assent explanation and consent form

    a) Consent explanation
o    Title
o    Introduction
o    Objectives of the study
o    Benefits
o    Risks
o    Compensation mechanism  if any
o    Alternative treatments
o    Voluntarism
o    Type of specimens and amount to be obtained
o    Follow up schedules if applicable/expected time in the study
o    Information on researchers and telephone numbers in case to be contacted
o    Information on the KNH/UON/ERC in case they need  to contact the committee (telephone numbers)
o    Any other necessary information about the study
o    Possible storage of specimen for further analysis  with the permission from the KNH/UON/ERC

    b) Consent form with signature page for the participant and witnesses;

2.    Study instruments
3.    Curriculum vitae
4.    Funding information
5.    Clinical   procedures and references; brochures,
6.     Laboratory procedures and references
7.    Maps where applicable
8.    Special information e.g. educational materials. 
9.    Any other relevant information    according to the study e.g. processes of pre-testing and post test counseling for special tests e.g. HIV



END




More information to researchers

1.    KNH/UON/ERC would like you to report Severe Adverse Events (SAE) as soon as they occur not more than 72 hours. Contact the KNH/UON/ERC for further details.  (Chairperson, Tel. No. +2542726300 Ext 44102)
2.    KNH/UON/ERC would like you to report protocol violations as soon as they occur. Contact the KNH/UON/ERC for further details.
3.    It is a requirement that you get permission for transfer of materials from one laboratory   to another for analysis; Material Transfer Agreement (MTA) between the laboratories involved.
4.    The ERC approval is given for one year only;  a renewal is necessary for any additional year (after receiving a satisfactory progress report).
5.    A letter indicating the stoppage of the project and reasons for this must always be provided to ERC.
6.    The committee might ask you to provide more information about the study as need will arise.
7.    Notify the KNH-UON ERC of the study summary at the end of study and provide  copies of publications out of the study.

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KENYATTA NATIONAL HOSPITAL/U.O.N/ ETHICS & RESEARCH COMMITTEE GUIDELINES FOR PROTOCOL DEVELOPMENT